presentation by leslie chong at 9th annual biotech showcase, san

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ASX:IMU

B Cell Based Antibodies for Immuno-Oncology

LeslieChongChiefExecutiveOfficer09-January-2017

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Notice: Forward Looking Statements

Any forward looking statements in this presentation have been prepared onthe basis of a number of assumptions which may prove incorrect and thecurrent intentions, plans, expectations and beliefs about future events aresubject to risks, uncertainties and other factors, many of which are outsideImugene Limited’s control. Important factors that could cause actual results todiffer materially from any assumptions or expectations expressed or implied inthis brochure include known and unknown risks. As actual results may differmaterially to any assumptions made in this brochure, you are urged to viewany forward looking statements contained in this brochure with caution. Thispresentation should not be relied on as a recommendation or forecast byImugene Limited, and should not be construed as either an offer to sell or asolicitation of an offer to buy or sell shares in any jurisdiction.

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What Does Imugene Do?

We are developing cancer immunotherapy drugs based on

antibodies

4

IMU’s Value Proposition

ü Promisingsciencewithimpeccableprovenanceinthehottestareaofcancertoday– immunooncology

ü BroadPipeline:HER-Vaxx &Mimotopes

ü BreastCancerclinicaltrialcomplete&onthecuspofrecruitmentonoursecondPhase1b/2clinicaltrialingastriccancer

ü TightshareregisterwithleadingFundManager,PlatinumAssetManagement

ü Frequent,rich,qualitynewsflowahead

ü AxelHoos Sr.VPofimmuno – oncologyatGSK,plusteamwithsuccessfultrackrecordindrugdevelopment

ü Lowmarketcap- undervaluedagainstASXpeers

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Imugene Operates in the most Promising area of Oncology Today…

Imugene isanimmunotherapycompanydevelopingB-cellbasedvaccinesinthemostpromisingareaofoncologytoday– IMMUNO-ONCOLOGY

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BCell

Antibody

TCell

What is Cancer Immunotherapy?

• Immunotherapyisthetreatmentofcancerwithsubstancesordrugsthatstimulatethepatient’simmuneresponse– knownasactiveimmunisation

• Unlikechemotherapy,immunotherapydrugsdonottargetthecancerdirectly

• Immunotherapyhelpsthepatient’sownimmunesystemrecognise &attackcancercells

• Typicalimmuneresponsesare:– BCellsmakingantibodiestoattackthecancer

– TCellsdevelopedbythethymustoattackthecancer

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Two Compelling Antibody Programs and Commercial Opportunities

Buildingonthemulti-levelsofyourownimmunesystem• Identificationofcancertargetsforvarietyofcancerindications• Immuneresponsesfromconjugatesandadjuvants• B-CellPeptidevaccinesagainstcheckpointtargets

Imugene’s PipelineBCellPeptidetechnology

Peptidesproducedviacomputeraidedprograms:

HER-Vaxx Vaccine

Peptidesidentifiedviamimotope technology

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What is an Antibody?A key Defense of the Immune System

BCells– arelikelittleantibodyfactoriesproducingmillionsofantibodiesagainstcancertargets

Inafactory UsingBcellsinyourownbody

Forexample,Roche’sHerceptin

Antibodies – LargeY-shapedprotein.Theyareexquisitelymadetoattachthemselvestoa targetsittingonaninvadingorganism

Thereare2waystomakeantibodies

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B-CellVaccinesofferauniqueopportunitytointerveneatmultiplepointsintheimmunesystemandcreateimmunememorywhichenhancesdurabilityofresponse.

Advantages of B-Cell Based Antibodies

Issue B-CellImmunotherapy MonoclonalAntibodies

Safety • StimulatestheimmunesystemtoproducenaturalAbs,potentiallysafer,asdemonstratedbyHER-Vaxx

• SyntheticAb,withsideeffects(includingventriculardysfunction,CHF,anaphylaxis,immunemediation)

Efficacy • PolyclonalAb responsereducesriskofresistanceandpotentiallyincreasesefficacy

• MonoclonalAb - singleshot

Durability • Antibodiescontinuouslyproducedalastingimmuneresponsetoinhibittumorrecurrence

• Halflifeupto12dayssometimesless

Usability • Potentiallylownumbersofvaccinationsrequiredperyear

• Requiresregularinfusion

Cost • Lowcostofproductionenablesgreaterpricingflexibilityfacilitatingcombinationsandopeningupadditionalmarkets

• Expensivecourseoftreatment>USD100KperyearintheUS

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A Mimotope Produces a Copy of an Antibody

• Amimotope isasmallmolecule,oftenapeptide,whichmirrorsthestructureofanepitope,thespecifictargetanantibodybindsto.Becauseofthispropertyitinducesanantibodyresponsesimilartotheoneelicitedbytheepitope.

• Amimotope causesyourBcellstoproduceanantibodycopyoftheantibodyyouwantto“mimic”

• Potentialtoolforselectingnovelvaccinecandidatesagainstavarietyoftumors

• GreatlyextendsIMU’soncologyfranchiseandpipeline.

• MonoclonalantibodymarketcurrentlyatUS$60bnannually

• December,2016progressedthemimotope platformwithfilingof4newpatentapplications

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ASX:IMU

HER-Vaxx is a peptide vaccine being developed for HER2+ gastric cancer

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B-Cell

HER-Vaxx: Mechanism of Action – How it Works

HER-VaxxImmunotherapy

B-cellActivation

HER-VaxxAntibodySecretion

TumorCell

P4

P6

P7

3Peptides

ViahelperT-cells

HER-2/neu

P4

P6

P7

HER-Vaxx attacksthesametargetasthetheworld’slargestsellingbreastcancerdrugHerceptin

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Phase 1 in Breast Cancer, Completed at MedicalUniversity of Vienna

*Wiedermann et.al.,BreastCancerResTreat.2010Feb;119(3):673-83.

• 10patients• Alllatestagebreastcancerpatients

• HER-2+/++• Lifeexpectancy>4months• ConductedatMedicalUniversityofVienna

❶ SafetyandTolerability

❷ Immunogenicity:antibodies andcellularresponses

Design• Patientsdevelopedanti-HER-2antibodies• Inductionofcytokines(Th1biased;IFNγ)• InductionofmemoryT&Bcellspostvaccination

• ReductioninTreg cellspostvaccination,indicatingstrongvaccineresponse

• Antibodiesinduceddisplayedpotentanti-tumoractivity

• Promisingresults- Patientswereendstageandnotprimarytargetgroup

• ReviewedinPeerPublication

ClinicalEndpoints

Results

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Ph1b/2 Formulation

HER-Vaxx Has Been Considerably Optimised Since Phase 1a

FirstGeneration• ThreeseparateBCellepitopesdeliveredinvirosomes (usedinPhase1a).

Third Generation • changed the delivery

system from virosomesto CRM197 (which gave CD4 T-Helper response), and added a montanide adjuvant

• >20x increase in antibody response in vivo (potentially extends patent life to 2036)

Second Generation • incorporated the three

B Cell epitopes into a single 49-mer peptide

• > 2x increase in antibody response in vivo compared to three single epitopes (extended patent life to 2030)

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0.00

0.20

0.40

0.60

0.80

1.00

1.20

1.40

1.60

OD 3 w. after 3 doses vacc.

8 w. after 3 doses vacc.

16 w. after 3 doses vacc.

6 mo. after 3 doses vacc.

Pre-immunization

10 25 50

P467-CRM-Montanide (µg)

HER-Vaxx Has Been Significantly Enhanced by the Carrier System and Adjuvant

In the mouse model the new formulation sees circulating antibodies maintained for 6 months which equates to many years in humans.

Her-2/neu specific IgG kinetic, after last immunization

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Phase 1b/2, in Gastric Cancer

• Openlabel

• ~18patientsin3cohortsofupto6ptspercohort

• Combinationwithchemo

• Endpoints:– RecommendedPhase2

DoseofHER-Vaxx– Safety:anyHER-Vaxx

toxicity– Immunogenicity(anti-

HER-2antibodytitres))

Phase1blead-in Phase2• Openlabel

• ~68patientsfromsitesinAsia

• Combinationwithchemo

• Randomized

• PrimaryEndpoints:– OverallSurvival– Progression-FreeSurvival

• Secondaryendpoint:– Immuneresponse

08-Nov,2016:Phase1b/2CommencesQ1,2017:PatientEnrolledQ1-Q2,2017:EarlyPatientDataAvailableQ32017:InterimPh1bPatientDataAvailableQ42017:FinalPh1bPatientDataAvailable

✓

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Huge Gastric Market Opportunity

• Gastriccanceristhesecondleadingcauseofcancermortalityintheworld&itsmanagement,especiallyinadvancedstages,hasevolvedrelativelylittle

• ~20%patientswithmetastaticgastriccancerareHER-2positive

• Surgery,chemotherapy,radiation&Herceptinarethekeytreatments

• Inmanycountries,particularlyAsia,chemotherapysuchascapecitibine and5-FU,isthestandardofcare,notHerceptin

• Asiaisthelargestmarketforgastriccancerglobally

Chemotherapy

Monoclonalantibody

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Licensee Licensor TotalSize(US$M)

Upfront(US$M)

Subject Stage PrimaryRxArea

1 Sanofi Hanmi $4,266 $445 Sanofl todevelopHanmi's Portfolio(specifically3assets)oflong-actingdiabetestreatment

Reformulation Endo/Meta

2 AstraZeneca lonis(fka Isis)

$4,090 $65 Discoveryanddevelopmentofantisensetherapiesforcardiovascular,metabolicandrenaldiseases

Discovery Diversified

3 Vertex CRISPR $2,625 $75 VertexandCRISPRtouseCR1SPR-cas9geneeditingtechnologytodiscoveranddevelopnewtreatmentforgeneticdiseases


4 Gilead Galapagos $2,075 $300 GileadSciencestodevelopandcommercializeGalapagos'filgotlnlb againstrheumatoidarthritis

PhaseII Al/lnflam

5 Pfizer Heptares $1,890 Undisclosed Heptares andpfizer todevelopnoveldrugstargetingGPCRagainstmultipletherapeuticindications


6 BMS FivePrime $1,740 $350 BMStodevelopandcommercializeFlve Prime'sCSFlR antibodyprogram,includingFPA-008forimmunologyandoncology

PhaseI Diversified

7 Sanofi Lexicon $1,730 $300 Sanofi todevelopandcommercializeLexicon'ssotagliflozin againstdiabetes,withanoptiontolicense

PhaseIII Endo/Meta

8 Amgen Xencor $1,702 $45 AmgentodevelopandcommercializeXencor'sbispecific cancerimmunotherapyandinflammationprograms

Preclinical Diversified

9 Sanofi Regeneron $1,665 $640 PD-1inhibitorandothernewimmuno-0ncologyantibodies,withanoption

PhaseI Cancer

10 Ultragenyx Arcturus $1,570 $10 Arcturus andUltragenyx todiscoveranddevelopmRNAtherapeuticsusingUNAOligomerchemistryandLUNARnanoparticledeliveryplatform


2015 Big Pharma Antibody Deals20%ofthetop10BigPharma dealsin2015wereintheantibodyspace

Topten2015licensingtransactionsbyannouncedtotalsize

$640Mup-frontPhase1

$350Mup-frontPhase1

19HighlightsindicatePhaseILicensingSource:ThomsonReuters11Jan16,“LifeSciencesDealmaking 2015”

What Could an IMU Deal Look Like?

Licensee Licensor Upfront($M) Equity($M) Stage RxAreaSanofi Regeneron $640 PhaseI CancerCelgene MedImmune/AZ $450 PhaseIII CancerSanofi Hanmi $445 Reformulation Endo/MetaBristol-MyersSquibb FivePrime $350 PhaseI DiversifiedAstellas lmmunomic $300 Discovery Al/lnflamGilead Galapagos $300 $425 PhaseII Al/lnflamSanofi Lexicon $300 PhaseIII Endo/MetaMedlmmune /AZ. Innate $250 PhaseII CancerAllergan Merck $250 PhaseII NeurologyNovartis Aduro $200 $25 Preclinical CancerCelgene Juno $150 $850 PhaseII DiversifiedCelgene Nurix $150 Discovery DiversifiedMerckKGaA lntrexon $115 Discovery CancerCelgene Lycera $105 PhaseI CancerJanssen Hanmi $105 PhaseI Endo/MetaBayer lonis (fka ISIS) $100 PhaseII CardiovascularDiaVax CityofHope $100 PhaseI ViralInfectionBayer lonis (fka ISIS) $100 PhaseII HematologicMerck NGM $914 $106 Preclinical Endo/MetaVertex Parion $80 PhaseII PuIm/Resp

Top20LicenseswithUpfrontPayments>$50m

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Valuation and Licensing Deals in Immuno-Oncology

LicensingDeals Upfront(includesequity&cash)USDm

Milestonepayments(USDm)

UpfrontPaymentas%ofTotal

Totaldealsize

High 999.8 1835 100% 2,012.3Mean 87.6 433 22.9% 514.6Median 35.0 309 10.3% 363.5Low 1.0 0 0.7% 1.0

The average total deal size is $514.6m, and the median deal size is $363.5m

ValuationofCompanies

LicensingDeals

Company Valuation(USDm) DevelopmentStageofleaddrugAgios Pharmaceuticals,Inc. $1.829 Phase3Karyopharm Therapeutics,Inc. $288 Phase2Dicerna Pharmaceuticals,Inc. $68 PhaseIImmuneDesignCorp. $167 Phase2HeatBiologics,Inc. $14 Phase2LoxoOncology,Inc. $514 PhaseIEpizyme,Inc. $597 Phase2KitePharma,Inc. $2,609 Phase1/2IderaPharmaceuticals,Inc. $185 Phase1/2Ignyta,Inc. $213 Phase1/2InovioPharmaceuticals,Inc. $716 Phase2FivePrimeTherapeutics,Inc. $1.150 PhaseIOncoMed Pharmaceuticals,Inc. $387 Phase2

Mean $672

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Sample News Flow in the next 12 Months

ü Patentfilingsonmimotopes (2H,2016)ü PatientsdosedinthePhase1b/2trialingastric

cancer(1H,2017)ü RecruitmentprogressandinterimPhase1b/2data

(1H,2017)

ü Firstmimotope drugcandidateidentified(1H,2017)

ü Preclinicalinvivo/vitroresults(2H,2017)ü FinalPhase1b/2trialreadout(2H,2017)

mimotopeHER-Vaxx

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IMU broadens pipeline with acquisition from Baker IDI

ü ExclusiveagreementwithBakerIDI

ü Oncologyrightstodevelopaportfolioofsmallmoleculeargininemodulatorsforcancertreatment

ü ArginineisacriticalaminoacidforthehealthofcancerfightingT-cellsanddepletionofitlimitstheeffectivenessofT-cellstofighttumors

ü BakerIDIcompoundsincreasetheavailabilityofarginineinthecellularenvironment

ü MinimalcostandresourcesrequiredforPOCin2017

ü Newpatentfiledtoprotectcompoundsinthefieldofcancerandimmuno-oncology,includingcombinationwithcheckpointinhibitors

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LeslieChongChiefExecutiveOfficer• Over19yearsofoncologyexperienceinPhaseI- IIIofclinicalprogramdevelopment

• Leadershiproleinvolvementin2marketedoncologyproducts

• PreviouslySeniorClinicalProgramLeadatGenentech,Inc.,inSanFrancisco

PaulHopperExecutiveChairman• International&ASXbiotechcapitalmarketsexperienceparticularlyinimmuno-oncology&vaccines

• ChairmanofViralytics,DirectorofPrescient,FounderofPolynoma LLC,formerDirectorpSivida,Somnomed &Fibrocell Science

• HeadofLifeSciencesDesk&AustraliaDeskatLosAngeles-basedinvestmentbank,Cappello Group

Dr AxelHoosNon-ExecutiveDirector• CurrentlyVicePresidentOncologyR&DatGlaxoSmithKline

• PreviouslyClinicalLeadonIpilumimab atBristol-MyersSquibb

• Co-Directorofthethink-tankCancerImmunotherapyConsortium;Imugene ishisonlyBoardseatworldwide

A Team with Track Record in Drug Development

ProfUrsulaWiedermannChiefScientificOfficer• Co-inventorofHer-Vaxx;inventorofmimotope platformtechnology

• ProfessorofVaccinology atMedicalUniversityofVienna

Dr NickEdeChiefTechnologyOfficer• Over25yearspeptidevaccineanddrugdevelopment

• FormerCTOConsegna,CEOAdistem Ltd,CEOMimotopes P/L,COOEQiTX Ltd(ZingoTX &VacTX)

• VPChemistryChiron(nowNovartis),ResearchFellowCRCVaccineTechnology

Dr AnthonyGoodClinicalProgramManager• Over15 yearsoncology&immunologyexperienceinglobal clinicaldevelopment programs.IntegraltothedevelopmentofsignificantnewmedicinesincludingViagra,Revatio,Lipitor, SelzentryandSomavert.

• Ex PfizerGlobalResearchandDevelopment,CovanceClinicalandPeriapprovalServices andWesternSydneyUniversity

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Business Strategy and Partnering Opportunities

2017-2018?

Phase1bMimotope+others

2017-2018

Phase1bGastricStudy

2017

BigPharma?

License/Partner

25

Options on issue (as at Dec. 2016)

Substantial holders (as at Dec. 2016)ASX:IMU, ISIN: AU000000IMU9

*Average

Our Stock

No of options Exercise Price Expiry

Listed (IMUO) 371,166,262 $0.015 31-Mar-17Unlisted 49,000,000 $0.0173* 30-Oct-17*TOTAL 420,166,262 $0.0155* 18-May-17*

Market Cap (22/Dec/16)

$32.5M AUD, $23.5M USD

Ordinary Shares 2.17 billion12 month price range 0.7 cents – 2.1 cents AUDAvg daily volume 10.5M shares (last three months)Investment to Date ~$12.2 mCash & Equivalents $3.82M as of 22/Dec/2016

No. of Shares % Capital

Platinum Asset Management

213,846,553 9.88%

Webinvest Pty Ltd<OLSB Unit A/C>

101,000,000 4.66%

National Nominees Limited

66,424,732 3.07%

Tisia Nominees 65,666,666 2.39%

Sarah Cameron 51,817,073 1.39%

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IMU’s Value Proposition

ü Promisingsciencewithimpeccableprovenanceinthehottestareaofcancertoday– immunooncology

ü BroadPipeline:HER-Vaxx &Mimotopes

ü BreastCancerclinicaltrialcomplete&onthecuspofrecruitmentonoursecondPhase1b/2clinicaltrialingastriccancer

ü TightshareregisterwithleadingFundManager,PlatinumAssetManagement

ü Frequent,rich,qualitynewsflowahead

ü AxelHoos Sr.VPofimmuno – oncologyatGSK,plusteamwithsuccessfultrackrecordindrugdevelopment

ü Lowmarketcap- undervaluedagainstASXpeers

27

ASX:IMU

Contact

[email protected]+61458040433

28

Appendix

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• MedicaloncologistattheMemorialSloanKetteringCancer• Specializesinthetreatmentofmalignanciesofthegastrointestinaltract,includingesophagusandstomachcancers.

Imugene Science Advisory Board

Christoph ZieliniskiMD

Ursula WiedermannMD, PhD

Neil SegalMD, PhD

Yelena JanjigianMD

• Director, Clinical Division of Oncology and Chairman, Department of Medicine at Medical University Vienna, Austria.

• Coordinator of the Comprehensive Cancer Center at Medical University Vienna and the General Hospital in Vienna, Austria.

• President, Central European Cooperative Oncology Group (CECOG).

• Chief Science Officer• Professor of Vaccinology and Head of the Institute of Specific

Prophylaxis and Tropical Medicine of the Medical University Vienna.• Speaker of the newly founded Centre for Geographic Medicine at the

Medical University Vienna

• Oncologist at the Memorial Sloan Kettering Cancer Center.• He holds a Doctorate of Medicine and Philosophy from University of the

Witwatersrand in South Africa.

30

Phase Ia Study Design*

*BreastCancerResTreat.2010Feb;119(3):673-83.

Patientinclusion criteria• Metastatic breast cancer• HER2+,++• ER/PRpos.• Lifeexpectance >4mo

Primaryendpoint• Safety &Tolerability

Secondary endpoint• Immunogenicity

– Specific antibodies– Cellular responses

Blood draw

Vaccination with10μg of eachpeptide antigen

D0 D28 D56 D84

Administration & Readout Schedule

31

Patient Characteristics – Ages 55-84 *

Patient ID Age Metas. disease since Prior chemotherapy Current antihormonal therapy

1 55 Oct. 2006 no Anastrozol

2 66 May 2004 yes (1 adj) Fulvestrant

3 84 Mar. 1999 no Anastrozol

4 79 Sept. 2003 no Anastrozol

5 67 Apr. 2004 no Fulvestrant

6 69 Sept. 2004 no Anastrozol

7 60 Aug. 2002 yes (3 met) Fulvestrant

8 76 Apr. 1999 no Fulvestrant

9 63 Jun. 2006 yes (1 met) Exemestan

10 70 Apr. 2008 No Anastrozol

* Breast Cancer Res Treat. 2010 Feb;119(3):673-83.

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Safety and Tolerability – Few Grade 1 Local Reactions, None Systemic*

Patient ID Local vaccination reaction grade Systemic grade 3/4 toxicity

1 1 no

2 0 no

3 0 no

4 1 no

5 1 no

6 0 no

7 0 no

8 0 no

9 1 no

10 0 no


33

c.

29

Phase I - Secondary Endpoint: Immunologic Responses

kappa IgG lambda IgG0

1

2

3

Her

-2/n

eu a

b tit

er in

crea

se

pre- post- pre- post- pre- post-0

1020304050607080

P4 P6 P7

pept

ide

ab ti

ter

pre- post-0

100200300400500600700800

IFN

- γγ γγ p

g/m

lpre- post-

0100200300400500600700800

TNF-αα αα

pg/

ml

pre- post-0

20

40

60

80

100

120

140

IL-2

pg/

ml

P<0.05

185 kDa

1 2 3 4

Cellular responses show Th1 profile

• 8/10 developed significant anti-peptide antibody levels• In all but one the antibodies were also directed against Her-2/neu • The majority also showed a 4-fold increase in influenza titers (HHT)16

Phase 1 Secondary Endpoint –Immunologic Responses

• 8/10developedsignificantanti-peptideantibodylevels• InallbutonetheantibodieswerealsodirectedagainstHer-2/neu• Themajorityalsoshoweda4-foldincreaseininfluenzatitres (HI)

c.

29



1

2

3

Her

-2/n

eu a

b tit

er in

crea

se


1020304050607080

P4 P6 P7

pept

ide

ab ti

ter

pre- post-0

100200300400500600700800

IFN

- γγ γγ p

g/m

lpre- post-

0100200300400500600700800

TNF-αα αα

pg/

ml

pre- post-0

20

40

60

80

100

120

140

IL-2

pg/

ml

P<0.05

185 kDa

1 2 3 4



c.

29



1

2

3

Her

-2/n

eu a

b tit

er in

crea

se


1020304050607080

P4 P6 P7

pept

ide

ab ti

ter

pre- post-0

100200300400500600700800

IFN

- γγ γγ p

g/m

lpre- post-

0100200300400500600700800

TNF-αα αα

pg/

ml

pre- post-0

20

40

60

80

100

120

140

IL-2

pg/

ml

P<0.05

185 kDa

1 2 3 4



c.

29



1

2

3

Her

-2/n

eu a

b tit

er in

crea

se


1020304050607080

P4 P6 P7

pept

ide

ab ti

ter

pre- post-0

100200300400500600700800

IFN

- γγ γγ p

g/m

l

pre- post-0

100200300400500600700800

TNF-αα αα

pg/

ml

pre- post-0

20

40

60

80

100

120

140

IL-2

pg/

ml

P<0.05

185 kDa

1 2 3 4





34

Reduction in Regulatory T Cells*

• SignificantlyhighernumberofCD4+Foxp3+regulatoryTcellsintumour patientsthanhealthycontrols

• VaccinationsignificantlyreducedTregcellsinbothgroups

c.

30

• Significantly higher number of CD4+Foxp3+ regulatory T cells in tumor patients than healthy controls

• Vaccination significantly reduced T reg cells in both groups

pre- post- pre- post-0.0

2.5

5.0

7.5

10.0

patients normal donors

p=0.007

p=0.033

%C

D4+

CD

25+F

oxp3

+

Phase I - Regulatory T cells:Cancer Patients vs.Healthy Controls

0.94 2.1288.74 8.20

100 101 102 103 104

post-vaccinationpre-vaccination

CD4+CD25+

100 101 102 103 104

2.29 6.2164.26 27.24

0.77 2.5187.16 9.56

Pat 01

Pat 02

Normal donor

100 101 102 103 104

1.31 4.3673.22 21.10

100 101 102 103 104

0.86 7.58 65.78 25.79

Data.026

100 101 102 103 104CD25 PE

1.06 8.32 60.84 29.78

CD

4+Fo

xp3+

c.

30

• Significantly higher number of CD4+Foxp3+ regulatory T cells in tumor patients than healthy controls

• Vaccination significantly reduced T reg cells in both groups

pre- post- pre- post-0.0

2.5

5.0

7.5

10.0

patients normal donors

p=0.007

p=0.033

%CD

4+CD

25+F

oxp3

+

Phase I - Regulatory T cells:Cancer Patients vs.Healthy Controls

0.94 2.1288.74 8.20

100 101 102 103 104

post-vaccinationpre-vaccination

CD4+CD25+

100 101 102 103 104

2.29 6.2164.26 27.24

0.77 2.5187.16 9.56

Pat 01

Pat 02

Normal donor

100 101 102 103 104

1.31 4.3673.22 21.10

100 101 102 103 104

0.86 7.58 65.78 25.79

Data.026

100 101 102 103 104CD25 PE

1.06 8.32 60.84 29.78

CD4+

Foxp

3+

CD

4+Fo

xp3+

CD4+CD25+


35

Excellent Immunogenicity, even at low dose, and in Patients ages up to 84 years, with no Cardiotoxicity

• Strongimmunogenicityin8/10patientsinPhase1studywith10μg of peptide antigen

• Goodcorrelationwithcellularresponses(cytokines)

• Safeandwelltolerated,inparticularnocardiotoxicity

• Protectiveefficacyofpeptidesdemonstratedinpreclinicaltumormodelinmiceshowingdelayofonsetandreducedtumorgrowth

*BreastCancerResTreat.2010Feb;119(3):673-83.

Pat. # Peptide-specific abP4, P6, P7

HER2-specific

ab

Infl. HIT

IL-2, IFNγ, TNF

T reg

1 ↑ ↑ ↑ ↑ - - - - ↓

2 ↑ ↑ ↑ ↑ ↑ ↑ ↑ ↑ ↓

3 ↑ ↑ ↑ ↑ (+/-) - ↑ - - ↓

4 ↑ ↑ ↑ ↑ ↑ - ↑ ↑ ↓

5 ↑ ↑ ↑ ↑ ↑ ↑ ↑ ↑ ↓

6 - - - - - ↓ ↓ ↓ ↓

7 ↑ ↑ ↑ ↑ ↑ - - - ↓

8 ↑ ↑ ↑ ↑ (+/-) ↑ ↑ ↑ - ↑

9 ↑ +/- +/- ↑ ↑ ↑ ↑ ↑ ↓

10 - - - - - +/- ↓ +/- ↓

HER-Vaxx breast cancer vaccine – Phase 1 trial 10 μg group

Antibody and cellular responses in human

36

Tumor Growth Inhibition in vivo*

• Prolongedtimetodiseaseprogression

• Immunization of c-neutransgenic mice (recognizedHER2cancer model)withtetanus toxoid-conjugatedpeptides P4,P6and P7

• Vaccinated animals showsignificant delay intumor onsetand reduced growth kinetics

• Co-administrationof IL-12further improves the vaccineperformance

Days after randomization

Preclinical study with tetanus toxoid–conjugated peptide antigens

d170 d235d65

Cum

ulat

ive

prop

ortio

n tu

mor

-free

Time to disease progression


37

No toxicity, in Particular No Cardiotoxicity

• RepeatdosetoxicitystudywithTT-conjugatedpeptidesinmice

• RepeatdosetoxicitystudywithHER-Vaxxinrats

• Localtolerability&immuno-genicitystudywithHER-Vaxxinrabbits

• Invitrotoxicitystudywithpurifiedserumfromimmunizedanimalsonratcardiomyocytes

In vitro toxicity study on rat cardiomyocytes

Rat cardiomyocytes


38

ASX:IMU

Contact

[email protected]+61458040433

presentation by leslie chong at 9th annual biotech showcase, san

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